On the Edges of Science and Law

The Creation of a Synthetic Cell Opens New Possibilities and Perhaps New Dangers

  by Jake Meyer

The biotechnology age has progressed at a rapid pace.  Every few years a new discovery in biotechnology leaves us wondering about new possibilities.  In 1997, Dolly the sheep was the first successfully cloned animal.  In 2000, the Human Genome Project announced that it had assembled the first working draft of the human genome.  And now in 2010 a team of researchers has created the first synthetic cell.  But sometimes lost with an eye-opening discovery is the story of Frankenstein and the question posed by Mary Shelley’s novel: How much tinkering should we do?  Or, updated for the 21st century, how should we regulate our new tinkering?

May 20, 2010, Researchers at the Craig Venter Institute created the first self-replicating synthetic bacterial cell.  A synthetic genome, 1.08 million base pairs long was designed by a computer, chemically made in a laboratory, and placed within a bacterium cell.  Through replication of the cell the original genome is lost and only the synthetic genome remains resulting in a new self-replicating cell controlled by the synthetic genome.  The discovery opens the possibility of engineering microbes that produce useful substances, such as vaccines and biofuels.  One possible use of this technology that is being explored is to construct genomes of photosynthetic bacteria to use light energy to produce hydrogen gas from water, which can be used as a fuel source. 

Rebecca Skloot's Journey into the Life of Henrietta Lacks

 by Lori Andrews

In 1890 a man sold the rights to his body after death to the Royal Caroline Institute in Sweden for research purposes.  Later, he tried to return the money and cancel the contract.  In the subsequent lawsuit, the court held that he must turn his body over to the Institute and also ordered him to pay damages for diminishing the worth of his body by having two teeth removed.

Today, it would be an anathema for a person's body to be used against his wishes or for a research subject not to be allowed to withdraw from a study.  In fact, the Uniform Anatomical Gift Act allows people to change their minds and withdraw a previous agreement to donate organs and tissue after their death and the Federal research regulations allow people to withdraw from studies without penalty or loss of benefits.  Yet the law is murky regarding research on a person’s tissue outside of his body and some modern doctors and researchers emulate the Royal Carolina Institute and stake their claims on materials from people’s bodies.     

In 1951, a 31-year-old African-American woman, Henrietta Lacks, died of ovarian cancer.  Without the knowledge or consent of Lacks or her family, her tissue was taken and made into a cell line that has been extremely valuable for research and is still sold today.  In an interview in 1994, her husband said, "As far as them selling my wife's cells without my knowledge and making a profit -- I do not like that at all.  They are exploiting both of us."                                                                                                            

                                                                                                                                                           Lori and Rebecca Skloot

Dorothy Nelkin and I wrote about Henrietta in our 2000 book, Body Bazaar: The Market for Human Tissue in the Biotechnology Age.  Over the past decade, journalist Rebecca Skloot probed more deeply.  In The Immortal Life of Henrietta Lacks, Skloot tells a moving story of how the unauthorized use of Henrietta's cells (known to scientists as HeLa cells) provided the foundation for most modern medical discoveries.  I caught up with Rebecca Skloot on her whirlwind book tour when she spoke at the Northwestern Medical School.

She described how Henrietta's cells formed the basis for much of the scientific enterprise across the world in the decades since her death.  Virtually every high school biology student, every medical student, and every vaccine maker has manipulated her cells.  While fortunes have been made on the foundation of the HeLa cells, her own children lacked access to education and basic health care.  In fact, when her children were contacted decades after her death by researchers wanting their tissue, they completely misunderstood what scientists meant by research on their mother’s cells.  They visualized their mother as still alive, in a cell, being researched upon.

But they are not the only people kept in the dark about tissue research.  How many people realize that their tissue is being used today without their knowledge and consent?  Over 282 million archived and identifiable pathological specimens from more than 176 million individuals are being stored in United States repositories.  Some specimens are anonymized or coded and not identified with specific individuals; others carry patient names or codes that allow personal identification.  Virtually everyone has his or her tissue "on file."

Expanding markets have increased the value of this tissue, and institutions -- hospitals, research laboratories, and the state and federal repositories that store tissue samples -- find they possess a capital resource.  Medical centers have deals in place with biotech companies to do genetic research on their hospital patients’ tissue without the patients' permission.

This lackadaisical approach to consent has recently been called in question.  A Native American group, the Havasupai, gave tissue to a scientist for research on diabetes.  Instead, the scientist undertook research about schizophrenia and in-breeding, which stigmatized the Havasupai, and research about geographical origins, which conflicted with the Havasupai's religious beliefs.

When the researcher was challenged in federal court, the judge found that the Havasupai had asserted valid claims for intentional infliction of emotional distress, negligent infliction of emotional distress, civil rights violations, negligence and gross negligence.  In April 2010, the researcher's university settled with the Havasupai, paying $700,000 to 41 members of the tribe for using their tissue without appropriate informed consent. 

The attention being paid to Skloot's excellent book and the good news of a settlement in the Havasupai case are spurring societal discussion about the use of tissue samples.  Clear laws and regulations are needed to assure that no one’s tissue is used without specific informed consent. 

The specifics of Henrietta Lacks saga will soon be made into a movie, with Oprah as an executive producer.  But her story affects us all.  Hospitals, universities, research centers, and private depositories retain pathology samples and genetic data collected in the course of surgical procedures or research projects -- a fact unknown to most patients.  New laws are needed to make sure we are not a nation of guinea pigs.

Should Payments to Egg Donors Be Limited?

 by Jake Meyer

The New York Times published a May 10, 2010 article about payments to women who donate their eggs titled “Payment Offers to Egg Donors Prompt Scrutiny,” and also asked the question of The New York Times readers Should Egg Donors Be Paid?  The process of donating eggs is time consuming, involves discomfort, and carries some physical risks to the donor, so do you compensate the donor?  Donation can cause abdominal swelling, mood swings, hot flashes and ovarian hyperstimulation syndrome, which can cause bloating, abdominal pain, and in some cases, blood clots, kidney failure, and other life-threatening ailments.  And if you do compensate an egg donor, how much do you pay an egg donor? 

The current practice in the U.S. is to allow egg donors to be paid.  The American Society for Reproductive Medicine has set guidelines for payments to egg donors.  The guidelines require justifications for payments over $5,000 and set a maximum compensation at $10,000 and also do not allow for the higher payments for specific traits.  However, advertisers are ignoring these guidelines.

A study by Dr. Aaron Levine at the Georgia Institute of Technology found that out of a sampling of 100 ads from 63 different college campuses, over a quarter of those ads exceeded the $10,000 maximum compensation guidelines set by the American Society for Reproductive Medicine.  The ads also offered higher average payments at schools with higher average SAT scores – ads averaged $2000 more for every 100 point difference in the average SAT scores.  Ads in the newspapers at Yale, Princeton, and Harvard offered $35,000 and an ad in the newspaper at Brown offered $50,000.

Are these guidelines necessary?  Should couples looking to reproduce be allowed to pay whatever price they wish for a donor egg?  Critics fear that young women will see the amount of money offered for egg donation and may overlook or not understand the potential physical and psychological risks.  Should the offers for donated eggs allowed to be higher for specific attributes?  Is an offer asking to pay $50,000 for the eggs of a donor who is tall, athletic, Ivy League educated, and with a score of at least 1400 of 1600 on the SAT appropriate?  Or are offers like this more akin to eugenics, where couples using donated eggs to conceive are paying higher premiums and selectively breeding certain traits.  The ASRM guidelines seem reasonable when the risks that an egg donor undertakes are weighed against the concern that women will donate against their best interests because of a large pay day.  Setting a limit on what an egg donor can be paid allows for an egg donor to be adequately compensated, and also addresses the issue eugenics-like trait selection.  Efforts should be made to ensure that these guidelines are more strictly followed.

Nano Ice Cream – Rich Texture, Low in Fat, and High in Unknown Risk

  By Jake Meyer

At ISLAT we've done studies on the legal issues surrounding nanotechnology for both the Department of Energy and the National Science Foundation, but the issue of nanotechnology has not reached the general public so it is refreshing to see an in depth analysis as part of an AOL News Special Report.  The AOL News Special Report is a three part series written by Andrew Schneider that explores the health risks nanotechnology introduce and the current regulatory efforts to protect workers, consumers, and the environment from these risks. 

The first article in the series is titled "Amid Nanotech’s Dazzling Promise, Health Risks Grow."  This title is apt for the entire series as the issues that are continually raised are the great possibilities that nanotechnology promises weighed against the health risks nanotechnology contains.  The worry is that too much regulation of nanotechnology will impede the development of amazing new technologies (along with it the economic boost new technologies provide).  But too little regulation might lead to widespread harm.

The article describes some of the nanotechnology products, such as the creation of nano-sized delivery systems that can be injected into the body to seek out cancer cells and deliver cancer-fighting drugs.  I previously wrote about other medical innovations that nanotechnology could enable such as nano robots that clean arteries of cholesterol and biosensors that allow a person with diabetes to monitor their glucose level without using a lancet.  Carbon nanotubes are stronger than steel and lightweight.  I previously wrote a blog about how carbon nanotubes could be the answer for the creation of space elevators.